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U.S. Department of Health and Human Services

Class 2 Device Recall LYMOL Medical Elite X Class Rigid Bronchoscope System

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 Class 2 Device Recall LYMOL Medical Elite X Class Rigid Bronchoscope Systemsee related information
Date Initiated by FirmJuly 29, 2021
Create DateSeptember 24, 2021
Recall Status1 Terminated 3 on October 04, 2022
Recall NumberZ-2562-2021
Recall Event ID 88485
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductLYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420
Code Information All distributed lots
Recalling Firm/
Manufacturer		 Lymol Medical Corporation
4 Plympton St
Woburn MA 01801-2917
For Additional Information ContactKim Abrano
781-935-0004 Ext. 116
Manufacturer Reason
for Recall		Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 9, 2021, the firm began notifying all consignees via email that the reprocessing instructions have changed. Included with each notification is a copy of the Urgent Notice, the revised IFU, and a response form. Customers were advised that the sterilization procedures were updated on November 15, 2020. Customers should discard and replace the obsolete procedures with the revised procedures included with the firm's mailing. The revised instructions have been uploaded to the LYMOL website at https://www.lymolmedical.com/instructions.cfm Customers with questions may contact the firm at Kabrano@lymolmedical.com.
Quantity in Commerce309
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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